GK1046
by Applied Medical Europe B.V. Netherlands EUDAMED
Ref GK1046Model AME STANDARD KIT
EMDN K010102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0607915PPIIB00114F | Date14 Jul 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Ame Standard Kit
- Model / Reference
- AME STANDARD KIT, GK1046
- Primary DI / UDI-DI
- 20607915145891
- Basic UDI-DI
- 0607915PPIIB00114F
- EMDN Code
- K010102 Minimally invasive surgery kits, single-use
- Device Class
- Class IIb
- Medical Purpose
- To gain minimally invasive access for instrumentation and to ligate and divide vessels, lymphatics and tissue bundles
Manufacturer details
- EUDAMED SRN
- NL-PR-000024031
Other devices from Applied Medical Europe
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- EUDAMED 20607915145891|0607915PPIIB00114F